Immune Pharma Starts Phase 2 Study For UC Drug

Immune Pharmaceuticals announced that it has begun patient screening for the Phase 2 trial of bertilimumab as an investigational treatment for ulcerative colitis (UC).

Bertilimumab is a recombinant human IgG4 monoclonal antibody that neutralizes human eotaxin-1 (eotaxin). The drug is being investigated in moderate to severe ulcerative colitis and Crohn's Disease. Immune Pharma is also conducting a Phase II trial of bertilimumab in bullous pemphigoid, an auto-immune dermatological condition designated as orphan disease.

The double blind, randomized, placebo controlled, parallel group Phase 2 proof-of-concept study will evaluate the drug’s safety and efficacy in adult patients with active moderate to severe UC. Patients will be chosen based on increased tissue eotaxin-1 as a biomarker. High levels of eotaxin-1 have been linked with severity of disease in ulcerative colitis and other autoimmune diseases, including Crohn’s and asthma.

Dr. Daniel Teper, Chairman and CEO of Immune, said, “Bertilimumab is among the first biologic drugs for auto-immune diseases with a biomarker strategy. We look forward to the results of this Phase 2 proof-of-concept clinical trial in Ulcerative Colitis as well as the previously initiated Phase 2 clinical trial in Bullous Pemphigoid, an orphan auto-immune disease of the skin.”

The trial will be split in three stages. An initial screening period will run up to two weeks, which will be followed by a four-week double-blind treatment phase. Finally, a safety and efficacy follow-up period will be conducted for about nine weeks.

Ulcerative colitis belongs to the class of inflammatory bowel disease (IBD) along with Crohn’s disease. Both UC and CD are characterized by painful and chronic inflammation resulting from the immune system’s attack against the gastrointestinal tract. IBD afflicts over 2.5 million people in the U.S.

Autoimmune diseases of the gastrointestinal tract have received considerable attention from drug makers this year. Last month, Pfizer announced a research partnership with the Crohn’s & Colitis Foundation of America (CCFA) to study inflammatory bowel disease. Avaxia Biologics is also at work conducting a Phase 1B clinical trial for its investigational UC drug AVX-470.